This position description intends to describe the general nature and level of work being performed by people assigned to this job. It is not intended to include all duties & responsibilities. The order in which the duties & responsibilities are listed is not significant. Position Summary: As part of the Data Management (DM) team, responsible for study-specific data management activities, including study set up, maintenance, data review, and database closure. Primary Responsibilities: • Reviews protocols and provides input relevant to data management issues. • Oversees/leads all data management activities for clinical studies either directly or overseeing a Clinical Research Organization (CRO). • Manages DM study activities with vendors, including external labs (transfer specifications and timelines) and Electronic Data Capture (EDC) vendor (DB build, User Acceptance Testing (UAT), maintenance, and lock). • Collaborates with other departments on clinical study start up (e.g. case report form (CRF) design), clean up, and closeout. • Responsible for study-specific DM documentation including the Data Management Plan, database creation/validation including edit checks, and query generation/resolution. • Responsible for clinical study data maintenance, data listings, entering queries, reviewing query resolutions, etc. • Provides input on general data management documents such as SOPs and CRF templates. Scope: Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways, exercising judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Determines methods and procedures on new assignments and may coordinate activities of other personnel. Networks with key contacts outside own area of expertise. Physical Requirements: While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment unless remote-based. Employee must occasionally lift and/or move up to 15 pounds.

Experience: • Minimum 8 years of experience in clinical data management. Must possess: • Hands on training and experience in clinical trial methodology and Good Clinical Practice. • Excellent understanding of all aspects involved in the data management responsibilities throughout a clinical trial. • Experience with Medidata’s Rave system including strong J-Review skills. • Proficient organizational and documentation skills. • Excellent written and verbal communication skills. • Strong understanding of regulatory guidance and regulations (eg. International Conference on Harmonisation (ICH), 21CFR Part 11, etc.). • Strong understanding of CDISC and CDASH standards. • Must be a team player who works effectively with other disciplines.

• BA/BS in Life Sciences or equivalent combination of relevant education and applicable job experience.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 7.25/hr.